CRA II – Sponsor Dedicated, Pulmonary Hypertension Studies

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits, on-site or remotely
• Evaluate site and site staff performance and recommend site-specific actions
• Communicate and escalate serious issues and develop action plans
• Verify informed consent, subject/patient confidentiality, safety and clinical data integrity
• Assess site processes and conduct source document review
• Verify clinical data in case report forms and resolve queries
• Verify compliance with electronic data capture requirements
• Manage investigational product inventory, reconciliation, storage, dispensing and administration when required
• Review and reconcile Investigator Site Files with the Trial Master File
• Document monitoring activities through letters, trip reports, communication logs and project documents
• Support subject/patient recruitment, retention and awareness strategies
• Track observations, status and action items to resolution
• Manage site-level activities, communications, budgets and timelines for assigned activities
• Act as liaison with study site personnel and ensure site team training and compliance
• Attend investigator, sponsor, global monitoring and clinical training meetings
• Support audit readiness and audit follow-up actions
• Provide site support across the real world late phase study lifecycle
• Perform chart abstraction and data collection
• Collaborate with sponsor affiliates, medical science liaisons and local country staff
• Train junior staff when requested
• Identify and communicate out-of-scope activities
• Suggest potential sites based on local treatment patterns, patient advocacy and HCP associations

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis
• Experience in pulmonary hypertension studies
• Ability to perform site qualification, initiation, monitoring, management and close-out activities in compliance with regulatory, ICH-GCP/GPP and protocol requirements
• Knowledge of local requirements for real world late phase study designs
• For US sites, compliance with site requests for medical and other personal information may be required for facility access

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Reasonable accommodations when appropriate